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Application of selective internal radiotherapy with yttrium-90 microspheres combined with systematic therapy in preoperative transformation therapy of potential resectable colorectal cancer with liver metastasis

Application of selective internal radiotherapy with yttrium-90 microspheres combined with systematic therapy in preoperative transformation therapy of potential resectable colorectal cancer with liver metastasis - SIRT with systematic therapy in preoperative transformation therapy of CRLM

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070306
Enrollment
Unknown
Registered
2023-04-08
Start date
2023-04-07
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer with liver metastasis

Interventions

A:selective internal radiotherapy with yttrium-90 microspheres combined with systematic therapy
B:systematic therapy

Sponsors

Fujian Medical University Cancer Hospital, Fujian Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed colorectal adenocarcinoma (excluding mucinous adenocarcinoma); 2. According to MDT discussion and assessment, it is consistent with the potentially resectable liver metastasis of colon cancer; 3. At least one assessable liver disease focus (RECICT1.1); 4. PMMR/MSS type without BRAF gene mutation; 5. Age 18-75; 6. ECOG PS 0-1; 7. Child-Pugh score 50 x 10^9/L (no platelet transfusion or platelet growth-promoting factor treatment); WBC >= 3.0 x 10^9/L Hemoglobin > 85 g/L; (2) Liver function: ALT and AST 30 g/L; (3) Renal function: serum creatinine 50 mL/min; (4) Coagulation function: INR <= 1.5 x ULN APTT <= 1.5 x ULN PT <= 1.5 x ULN; 9. Sign the informed consent form voluntarily; 10. The serum pregnancy test was negative.

Exclusion criteria

Exclusion criteria: 1. There are contraindications to angiography and super selective catheterization, or there is a history of allergy to contrast agents and anesthetics; 2. Have received liver radiotherapy before; 3. Liver diffuse metastasis; 4. Incomplete function of the bile duct system, previous biliary interventional therapy, or damage of ampulla of liver and pancreas (Vater ampulla); 5. Use antiangiogenic inhibitor within 28 days before technetium [99mTc] - MAA injection; 6. The average absorbed dose of the lung calculated according to the pulmonary shunt ratio is>30 Gy (single treatment); 7. Technetium [99mTc] - MAA hepatic artery perfusion imaging indicates gastrointestinal shunt, which cannot be corrected by vascular intervention technology; Or other non-correctable extrahepatic collateral tumor blood supply; 8. Pregnant or lactating female patients; 9. Severe pulmonary insufficiency (FEV1/FVC < 50%, or MVV < 50 L/min), or a history of interstitial lung disease; 10. Portal hypertension with ascites or gastric varices bleeding history within 6 months before screening; 11. Active infection: HIV-positive or acquired immunodeficiency syndrome (AIDS) patients; Uncontrolled HBV and HCV infected patients; 12. History of severe arrhythmia or heart failure; 13. Active autoimmune diseases requiring systematic treatment; 14. Other researchers consider it inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
Objective response rate, ORR;Surgical conversion rate;Recurrence free survival, PFS;

Secondary

MeasureTime frame
Overall survival, OS;adverse event;

Countries

China

Contacts

Public ContactJingfeng Liu

Fujian Medical University Cancer Hospital, Fujian Cancer Hospital

drjingfeng@126.com+86 1390529580

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026